US11628141B2ActiveUtilityA1

Method for producing an, in particular oral, active substance laminate, and active substance laminate, in particular oral active substance laminate

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Assignee: LTS LOHMANN THERAPIE SYSTEME AGPriority: Apr 6, 2017Filed: Apr 5, 2018Granted: Apr 18, 2023
Est. expiryApr 6, 2037(~10.7 yrs left)· nominal 20-yr term from priority
A61K 9/006A61K 9/1694A61K 47/38A61K 9/7007A61K 9/0056A61F 2013/00646
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PatentIndex Score
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Cited by
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References
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Claims

Abstract

The invention relates to a method for producing an active substance laminate, especially an oral active substance laminate ( 100 ), having at least one active-substance-containing layer ( 31 ), which is arranged on a substrate ( 20 ), wherein the method comprises the following steps: a) providing a substrate ( 20 ) having an upper side ( 21 ) and an underside ( 22 ); b) applying an active-substance-containing mass ( 24 ) in a gap ( 25 ) formed by a first rotating roller ( 26 ) and a second rotating roller ( 27 ); c) transporting the substrate ( 20 ) to the second roller ( 27 ) by means of a third rotating roller ( 28 ) in such a way that the active-substance-containing mass ( 24 ) is applied to the upper side ( 21 ) of the substrate ( 20 ) by the second roller ( 27 ) in the form of an active-substance-containing layer ( 31 ); d) transporting an intermediate laminate ( 30 ), formed by the substrate ( 20 ) and the active-substance-containing layer ( 31 ), to a drying device ( 40 ); and e) drying the intermediate laminate ( 30 ), especially the active-substance-containing layer ( 31 ).

Claims

exact text as granted — not AI-modified
The invention claimed is: 
     
       1. A method for producing an active substance laminate, having at least one active-substance-containing layer, which is arranged on a substrate, wherein the method comprises the following steps:
 a) providing a substrate having an upper side and an under side; 
 b) applying an active-substance-containing mass in a gap formed by a first rotating roller and a second rotating roller, wherein the gap between the first rotating, roller and the second rotating roller has a width of from 0.2 mm-0.9 mm; 
 c) transporting the substrate to the second roller by means of a third rotating roller in such a way that the active-substance-containing mass is applied to the upper side of the substrate in the form of an active-substance-containing layer to form an intermediate laminate by the second roller, wherein the rotation speed of the first rotating roller is 0.1 m/min-0.5 m/min, the rotation speed of the second rotating roller is 0.8 m/min-2.3 m/min and the rotation speed of the third rotating roller is 0.5 m/min-1.5 m/min, wherein the second roller has a rotation speed greater than the rotation speed of the third roller; 
 d) transporting the intermediate laminate, formed by the substrate and the active-substance-containing layer, to a drying device; 
 e) drying the active-substance-containing layer of the intermediate laminate in the drying device at a temperature of 30-120° C.; and 
 f) guiding the dried intermediate laminate through laminating rollers and forming the active substance laminate. 
 
     
     
       2. The method according to  claim 1 , wherein the underside of the substrate is releasably connected, to a carrier film. 
     
     
       3. The method according to  claim 1 , wherein solvent is removed as the active-substance-containing layer is dried. 
     
     
       4. The method according to  claim 1 , wherein the substrate is free from an active substance or contains an active substance. 
     
     
       5. The method according to  claim 1 , wherein the substrate is formed by at least two active-substance-free layers. 
     
     
       6. The method according to  claim 1 , wherein the first roller, the second roller and the third roller rotate in the same rotation direction. 
     
     
       7. The method according to  claim 1 , wherein said drying is carried out in a plurality of drying zones having different temperatures by means of an air jet. 
     
     
       8. The method according to  claim 1 , further comprising: g) rolling up the active substance laminate. 
     
     
       9. The method according to  claim 2 , further comprising:
 h) unrolling the active substance laminate; 
 i) optionally removing the carrier film; and 
 j) dividing the active substance laminate into multiple active substance laminate portions.

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